Vial: difference between revisions
Diff·revision 33 → 34·20:53, 10 Feb 2025
Difference between revision 33 and revision 34 of Vial. 7 lines changed; the page grew by 1,099 bytes.
| Revision 33 — 02:11, 2 Feb 2025 SupplyWatchSuri (talk) merge two short sections 16,052 bytes ±0 | Revision 34 — 20:53, 10 Feb 2025 CategoryBot (talk) bot: normalise citation format 17,151 bytes +1,099 | ||
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| 113 | Compendial fragmentation testing quantifies the propensity: a specified number of penetrations is made with a needle of specified gauge through closures on filled vials, the contents are filtered, and the visible fragments counted against a limit. Because the test is performed with a defined needle and technique, it characterises the closure rather than any particular pattern of use, and a closure that passes can still be cored by a blunt needle used repeatedly at one point.{{r|usp381,pheur329}} | 113 | Compendial fragmentation testing quantifies the propensity: a specified number of penetrations is made with a needle of specified gauge through closures on filled vials, the contents are filtered, and the visible fragments counted against a limit. Because the test is performed with a defined needle and technique, it characterises the closure rather than any particular pattern of use, and a closure that passes can still be cored by a blunt needle used repeatedly at one point.{{r|usp381,pheur329}} |
| 114 | 114 | ||
| + | 115 | == Sealing and capping == | |
| + | 116 | The stopper is retained by an aluminium ferrule crimped beneath the vial's neck flange. The crimp compresses the stopper flange against the sealing land of the vial, and it is that compression — not the stopper alone and not the ferrule alone — that produces the seal. | |
| + | 117 | ||
| + | 118 | The mechanical figure of merit is ''residual seal force'': the compressive force remaining on the stopper after crimping and after the elastomer has relaxed. Too little leaves an unreliable seal; too much can distort the stopper, damage the glass sealing surface or crack the flange. Residual seal force is measurable non-destructively and has become the conventional in-process control for capping, replacing subjective assessments such as attempting to rotate the cap by hand.{{r|kirsch1997,usp1207}} | |
| + | 119 | ||
| 115 | == References == | 120 | == References == |
| 116 | {{reflist}} | 121 | {{reflist}} |
| ⋮ | ⋮ | ||
| 128 | <ref name="ennis2001">Ennis RD, Pritchard R, Nakamura C, et al. "Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination." ''Pharmaceutical Development and Technology'' 6(3):393–405 (2001).</ref> | 133 | <ref name="ennis2001">Ennis RD, Pritchard R, Nakamura C, et al. "Glass vials for small volume parenterals: influence of drug and manufacturing processes on glass delamination." ''Pharmaceutical Development and Technology'' 6(3):393–405 (2001).</ref> |
| 129 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> | 134 | <ref name="fda2011">US Food and Drug Administration. "Advisory to Drug Manufacturers: Formation of Glass Lamellae in Certain Injectable Drugs" (March 2011).</ref> |
| + | 135 | <ref name="kirsch1997">Kirsch LE, Nguyen L, Moeckly CS. "Pharmaceutical container/closure integrity I: mass spectrometry-based helium leak rate detection for rubber-stoppered glass vials." ''PDA Journal of Pharmaceutical Science and Technology'' 51(5):187–194 (1997).</ref> | |
| 130 | 136 | ||
| 131 | == See also == | 137 | == See also == |
| ⋮ | ⋮ | ||
| 135 | * [[Beyond-use date]] | 141 | * [[Beyond-use date]] |
| 136 | * [[Reconstitution of lyophilised peptides]] | 142 | * [[Reconstitution of lyophilised peptides]] |
| + | 143 | * [[Underfilling]] | |
| 137 | 144 | ||
| 138 | {{DEFAULTSORT:Vial}} | 145 | {{DEFAULTSORT:Vial}} |